Abstract

A REVIEW OF STRATEGIC PLAN FOR PREVENTING AND MITIGATING DRUG SHORTAGES IN USA

Zinal Dushyantbhai Shah, Dr. Jignesh S. Shah*, Dr. Dilip G. Maheshwari

ABSTRACT

Drug shortages are a significant public health issue in the United States, and addressing shortages remains a top priority for FDA. Establishment of clear rules and guidelines for managing drug shortages is essential to overcome this issue. FDA has given this strategic plan to address drug shortages in the United States. Recently the president and congress have taken important actions which enabled FDA to learn more about possible shortages before they occur. These actions have helped FDA to prevent 78 shortages in the first three-quarters of 2014. This strategic plan is consisting of three sections. The first section is about identifying the causes of shortages, and describing current efforts by FDA’s to resolve existing shortages and disruptions in supply chain. The second section explains the actions FDA is taking to strengthen and expand its efforts to discuss shortages. The third section reviews potential actions for other stakeholders. This article reviews strategic plan for preventing and mitigating drug shortages drafted by food and drug administration in October 2013.

Keywords: Drug Shortages, Strategic Plan, Food and Drug Administration (FDA).